D-0108-2021 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 2, 2020
- Initiation Date
- October 23, 2020
- Termination Date
- January 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7176 bottles
Product Description
Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 Made in India, NDC 23155-050-01
Reason for Recall
Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
Distribution Pattern
USA Nationwide
Code Information
Lot #: 18029979, Exp 1/2021